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Trial registered on ANZCTR


Registration number
ACTRN12620000066987
Ethics application status
Approved
Date submitted
16/12/2019
Date registered
28/01/2020
Date last updated
28/01/2020
Date data sharing statement initially provided
28/01/2020
Date results information initially provided
28/01/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Optimising the radiotherapy planning and treatment for anal cancer
Scientific title
Optimising the radiotherapy planning and treatment for anal cancer
Secondary ID [1] 300099 0
Austin Health Project Number: ND 14/643
Secondary ID [2] 300100 0
RANZCR Project Number: 2015/RANZCR/007
Universal Trial Number (UTN)
U1111-1245-4665
Trial acronym
OPTIRAC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anal Cancer 315625 0
Condition category
Condition code
Cancer 313921 313921 0 0
Bowel - Anal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cohort: 10 patients with histologically proven squamous cell carcinoma (SCC) of the anus, presenting to Austin Health for chemo-radiotherapy from June 2015.

Observation: for up to 3 years post-radiotherapy.

Interventions additional to standard procedures for purpose of study are administered by qualified health professionals and include:

Pre-radiotherapy imaging:
During standard MRI imaging session – non-standard diffusion weighted MRI (dwMRI) and dynamic contrast enhanced (DCE) MRI scans within Radiology facility.
During standard CT simulation session – additional CT scan in prone position within Austin Radiation Oncology.

Post-Radiotherapy - 3-4 weeks post completion of radiotherapy - non-standard timepoint for these scans
MRI session – including dwMRI and DCE MRI scans within Radiology facility.
PET session - PET imaging within Austin Nuclear & Molecular Imaging department.

A number of imaging scans are required to map disease for targeting of radiotherapy (RT), including CT, PET and MRI. Each provides slightly different information about the position, shape and composition of the disease that is used by a Radiation Oncologist to define where to target the radiation and how much radiation to deliver. We aim to add an extra, non-standard MRI imaging sequence called a diffusion weighted (dwMRI) scan, to understand the characteristics of the disease and how its use may change the size or shape of the target area so as to ensure complete treatment coverage and improved outcomes from treatment. Additionally, the use of contrast with MRI, dynamic contrast enhanced MRI (DCEMRI) has been shown in other cancer sites to help better identify and show the disease and to show response to treatment, and we wish to verify this in anal cancer. These MRI imaging scans will be performed within a Radiology facility prior to radiotherapy planning as is is standard practice, with an additional

Participation in this research will not alter the treatment provided. This will be delivered to the high standards of Austin Health as per standard department protocol. Other than standard procedures, this study will require extra time to enable additional MRI sequences to be completed, and for an additional radiotherapy planning scan in the prone position to be taken, we would estimate this extra time to be approximately 30 minutes for the MRI and planning CT respectively.

During the planning process for radiotherapy you will receive two (2) standard CT scans, one with intravenous contrast, to further help define the area for treatment and to allow for an individualised radiotherapy treatment plan to be created. Standard scans are obtained with participants laying on their back, supine. As part of the research, all participants will receive one additional CT scan with participants positioned on their stomach, prone, resulting in a small amount of additional radiation dose.
Intervention code [1] 316378 0
Diagnosis / Prognosis
Comparator / control treatment
Each patient will act as their own control using pre-radiotherapy CT imaging & clinically used treatment planning and delivery method in the supine position.
Control group
Active

Outcomes
Primary outcome [1] 322313 0
Identify the differences in radiotherapy target volume definition on standard (CT, T1/T2 MRI and PET) versus non-standard imaging modalities (dwMRI & DCE-MRI).
Timepoint [1] 322313 0
2 years post-radiotherapy
Secondary outcome [1] 378064 0
To assess if PET imaging at the 1 month post-radiotherapy time point is equivalent to that at 3 months (current standard) in terms of tumour visualisation and inflammation as assessed by a Radiologist. This is a composite outcome.
Timepoint [1] 378064 0
2 years post-radiotherapy
Secondary outcome [2] 378066 0
To compare radiotherapy dose metrics, including target volume coverage dose and critical structure dose, between 3 radiotherapy planning and delivery methods. This is a composite outcome.
Timepoint [2] 378066 0
2 years post-radiotherapy
Secondary outcome [3] 378068 0
To compare radiotherapy dose metrics, including target volume coverage dose and critical structure dose, between supine and prone patient positioning. This is a composite outcome.
Timepoint [3] 378068 0
2 years post-radiotherapy
Secondary outcome [4] 378071 0
To explore and measure the effect of daily anatomical variation from planned dosimetry through demormable registration techniques using dose volume histogram (DVH) data for target and critical tissues.
Timepoint [4] 378071 0
2 years post-RT

Eligibility
Key inclusion criteria
Inclusion Criteria
• Histologically confirmed SCC Anal Canal confined to the pelvis
• ECOG Performance Status 0-2
• Age > 18 yrs;
• competent to give written informed consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Contraindication to MRI such as
• pacemaker
• cochlear implants
• some cardiac stents
• claustrophobia
• Allergy to Gadolinium (DCE scan)
• Contraindication to PET such as
• Poor renal function
• Gross metastatic disease
• Other illness that would impair ability to remain still/stable during treatment
• Healing/bleeding disorder
• Pregnancy
• Previous radiotherapy
• Unable to attend for the full course of treatment or trial related visits.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Single sequential prospective enrolment.
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
All data will be analysed to evaluate the statistical difference, if any. Descriptive statistics will be used to present all data. Cohort numbers represent the minimum reasonable to provide sufficient statistical weight, balanced with the rare nature of the disease and historical numbers presenting to Austin Health annually.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 15514 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 28877 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 304544 0
Charities/Societies/Foundations
Name [1] 304544 0
The Royal Australian and New Zealand College of Radiologists
Address [1] 304544 0
Level 9, 51 Druitt Street
Sydney NSW 2000
Country [1] 304544 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
145 Studley Rd,
Heidelberg VIC 3084
Country
Australia
Secondary sponsor category [1] 304821 0
None
Name [1] 304821 0
Address [1] 304821 0
Country [1] 304821 0
Other collaborator category [1] 281116 0
University
Name [1] 281116 0
Monash University
Address [1] 281116 0
Wellington Rd,
Clayton VIC 3800
Country [1] 281116 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304971 0
AUSTIN HEALTH HUMAN RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 304971 0
145 Studley Rd,
Heidelberg VIC 3084
Ethics committee country [1] 304971 0
Australia
Date submitted for ethics approval [1] 304971 0
21/11/2014
Approval date [1] 304971 0
02/06/2015
Ethics approval number [1] 304971 0
HREC/14/Austin/643
Ethics committee name [2] 304973 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [2] 304973 0
Wellington Rd,
Clayton VIC 3800
Ethics committee country [2] 304973 0
Australia
Date submitted for ethics approval [2] 304973 0
14/07/2015
Approval date [2] 304973 0
20/07/2015
Ethics approval number [2] 304973 0
CF15/2788 - 2015001138

Summary
Brief summary
The overall aim of this project is to identify best practice in the planning and treatment of radiotherapy for anal cancer. Through measuring the best options available for radiotherapy we aim to maximize the potential of radiotherapy to control disease and minimize treatment side effects for patients. As a rare cancer there is a relatively small amount of research and information available about the optimal radiotherapy procedures to be used in the treatment of anal cancer. This project aims to address this with respect to the planning and treatment options currently available.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98814 0
Dr Daryl Lim Joon
Address 98814 0
Radiation Oncology
Austin Health
145 Studley Road
Heidelberg VIC 3084
Country 98814 0
Australia
Phone 98814 0
+61 394962800
Fax 98814 0
Email 98814 0
daryl.limjoon@austin.org.au
Contact person for public queries
Name 98815 0
Mr Drew Smith
Address 98815 0
Radiation Oncology
Austin Health
145 Studley Road
Heidelberg VIC 3084
Country 98815 0
Australia
Phone 98815 0
+61 394962800
Fax 98815 0
Email 98815 0
drew.smith@austin.org.au
Contact person for scientific queries
Name 98816 0
Mr Drew Smith
Address 98816 0
Radiation Oncology
Austin Health
145 Studley Road
Heidelberg VIC 3084
Country 98816 0
Australia
Phone 98816 0
+61 394962800
Fax 98816 0
Email 98816 0
drew.smith@austin.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participant data will be collated when publicly disseminated. no individual participant data will be made available
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary